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Low Dense Polyethylene Snap Kover 20" X 20"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 01-2020
Identity
- Trade Name
- Snap Kover FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- Low Dense Polyethylene Snap Kover 20" X 20" EUDAMEDDisposable Equipment Cover FDA UDI
- Model / Reference
- 01-2020 EUDAMEDFDA UDI
- Description
- Disposable Equipment Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340015427 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00848340015427 EUDAMED
- 510(k) Number
- K850959 FDA UDI
- FDA Product Code
- JAA FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Low Dense Polyethylene Snap Kover 20" X 20" by Advance Medical Designs, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00848340015427 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3014e21d-dfaa-4d3e-8ae2-cb71d0bccee4 61 fields · synced Oct 6, 2026
- FDA UDI 6049575a-d2fb-4997-b576-249272263c93 34 fields · synced May 30, 2026